MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC METRX SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	9560523
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with a spinal product using a bed rail in a plif for a lumbar spinal canal stenosis.It was reported that during the operation, the hinge part of the bed rail was loose and was disassembled after the operation.The instrument broke and there was no fragment of the instrument remaining in the patient's body.The event was associated with a patient.It is unknown if there were patient symptoms or complications as a result of this event.This procedure was not a revision surgery.It is unknown if there was a delay in overall procedure time, in-patient hospitalization or prolongation of existing hospitalization necessary, and treatment or additional surgery performed as a result of this event.No further complications were reported/ anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with a spinal product using a bed rail in a plif for a lumbar spinal canal stenosis.It was reported that during the operation, the hinge part of the bed rail was loose and was disassembled after the operation.The instrument broke and there was no fragment of the instrument remaining in the patient's body.The event was associated with a patient.It is unknown if there were patient symptoms or complications as a result of this event.This procedure was not a revision surgery.It is unknown if there was a delay in overall procedure time, in-patient hospitalization or prolongation of existing hospitalization necessary, and treatment or additional surgery performed as a result of this event.No further complications were reported/ anticipated.
Additional Manufacturer Narrative
B5: additional information received, with regard to patient condition.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient was on the operating table when the malfunction occurred.The patient came in contact with the reported product.There were no patient symptoms or complications as a result of this event.
Additional Manufacturer Narrative
H3: product analysis part# 9560523 ; lot# my20e001- visual inspection confirmed the flex arm was returned with the screw handle disassembled.Optical inspection of the inner parts revealed normal wear from use.Functional inspection confirmed when the handle was reattached the instrument was able to tighten and loosen without any issues.The instrument appears to function as intended and there was no fault found.H6: updated eval.Code method, eval.Code result, and eval.Code conclusion post analysis.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: METRX SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13596942
• Report Number: 1030489-2022-00191
• Device Sequence Number: 5833880
• Product Code: LXH
• UDI-Device Identifier: 00721902322532
• UDI-Public: 00721902322532
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9560523
• Device Catalogue Number: 9560523
• Device Lot Number: MY20E001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 03/02/2022; 07/26/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 03/23/2022; 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown